Orexigen sets Contrave timetable

Point Loma  Orexigen Therapeutics may resubmit its weight loss drug Contrave for FDA approval by year end, the company said Tuesday.

If approved, Contrave would compete against two other newly marketed weight loss drugs; Belviq, introduced this year by San Diego-based Arena Pharmaceuticals, and Qsymia, which Mountain View-based Vivus began selling last year.

Orexigen said it expects interim analysis of an FDA-required study to be conducted by early December, making resubmission possible. Called the Light study, it is intended to provide additional safety information the FDA had requested for Contrave regarding cardiovascular risk.

The company has been waiting for enough "adverse cardiovascular events" to analyze in the placebo-controlled study.

Contrave combines bupropion, the active ingredient in the antidepressant Wellbutrin, with naltrexone, an anti-addiction drug.